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European Medical Device Regulation 2017/745

GMED North America, Inc.

Tuesday, October 15, 2019 at 8:30 AM - Wednesday, October 16, 2019 at 5:30 PM (PDT)

European Medical Device Regulation  2017/745

Ticket Information

Ticket Type Sales End Price Fee Quantity
Attendants (public) Oct 14, 2019 $1,900.00 $117.29
Attendants @ early bird Sep 27, 2019 $1,800.00 $111.20
Attendants (clients) Oct 14, 2019 $1,700.00 $105.12
Groups 3 person group Oct 14, 2019 $1,600.00 $99.03

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Event Details

Training for RA/QA Professionals of the Medical Device Industry:

 

Implementing the European Medical Device MD 2017/745  

        

 The European Regulation (EU) 2017/745 on Medical Devices (including Active Implantable Medical Devices or AIMDs) was published May 5th, 2017 and entered into force on May 25th, 2017. With May 26th, 2020 for application date, there is not a lot of time left for Medical Device companies to get up to speed.

 

GMED North America has designed a comprehensive training course to help companies prepare for their application to obtain and/or maintain CE marking for their medical device product(s) and :

  • Gain an understanding of the changes introduced by the European Regulation (EU) 2017/745 on Medical Devices;
  • Assess the impacts of those changes on their organizational and structural activities;

Over the course of 2 days, the attendees will learn about the new requirements to plan an efficient transition and ensure they are ready to:

  • Address the new Quality Management System (QMS) requirements;
  • Understand the Product Classification criteria’s and Conformity Assessment routes and how it applies to their device(s);
  • Assess the impacts on the Technical Documentation for Medical Devices in relation with Product Classification criteria’s and Conformity Assessment routes;
  • Identify the expectations with respect to the Clinical Evaluation, Clinical Data(s) and Risk Management;
  • Implement the requirements for labelling , the Unique Device Identification (UDI) and EUDAMED;
  • Address the expectations with respect to the requirements pertaining to the Post market Surveillance and Vigilance reporting (Periodic reports etc.);

 

Sign up today and join our intensive 2 day course on

 

European Regulation (EU) 2017/745 on Medical Devices

 

Acquire a solid foundation so that you and your team are prepared to tackle through practical cases and working sessions/discussions led by our Expert lead auditor, these new challenges.

 

Keywords: European Medical Devices Regulation 2017/745, MDR, Quality Management System (QMS) , Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Clinical Evaluation and Clinical Data, Post Market Surveillance, Vigilance reporting.

 

WHO SHOULD ATTEND

  • Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R& D specialists, Development, Manufacturing and Marketing Managers,
  • Internal and external Auditors
  • Importers
  • Distributors

REQUIRED LEVEL

  • Good knowledge and effective practice of the Directives 93/42/ EEC or /and 90/385 / EEC;
  • Familiar with the general principles of the European Regulation (EU) 2017/745 for Medical Devices;
  • The maximum number of participants per training session is set to 15 to guarantee a stimulating and practical working environment.

EDUCATIONAL RESOURCES

  • Presentations in PDF and binder copy of the European Regulation (EU) 2017/745 for Medical Devices;
  • Practical working sessions;
  • Course evaluation;
  • Lunch meeting with the trainer (Lead Auditor and Technical File Assessor for high risk devices);

Implementing the European Medical Device Regulation 2017/745

 

Day 1 & 2

 

8:30 am to 9:00 am – Breakfast;
9:00 am – 12:15 pm:

 

  • Regulation structure
  • Scope and Definitions
  • Actors and Responsibilities
  • Device Classification Criteria
  • Conformity Assessment routes
  • Quality Management System requirements
  • Technical Documentation
  • Post Market Surveillance and Vigilance reporting requirements
  • The Transition

 

12:15 pm – 1:00 pm - Lunch
1:00 pm – 5:00 pm:

 

  • Practical working sessions
  • Group workshop
  • Course Evaluation
  • Summary and Discussion with the trainer

 

Note GMED North America retains the right to cancel the training 7 days before the date if the number of attendees is insufficient.

 

Have questions about European Medical Device Regulation 2017/745? Contact GMED North America, Inc.

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When & Where


San, Diego, CA 92101

Tuesday, October 15, 2019 at 8:30 AM - Wednesday, October 16, 2019 at 5:30 PM (PDT)


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Organizer

GMED North America, Inc.

 GMED North America. is the subsidiary of GMED, leading Certification Organization & distinguished Notified Body (CE0459).

GMED is a leading Certification Organization and a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC).

 

GMED is also an Auditing Organization Recognized by the MDSAP Regulatory Authority Council and has been performing MDSAP audits since April 2015. GMED is accredited under the NF EN IEC/ISO 17021-1:2015 standard by COFRAC (Certificate № 4-0608), the French Accreditation Committee, to carry out Quality Management System Certification activities according to ISO 9001:2015 and ISO 13485:2016. 

 

Established in 1994, GMED is fully owned by LNE (e.1901), a State owned Industrial and Commercial Establishment (EPIC), and operates since August 1st, 2018 as a simplified joint stock company (SAS) within the LNE group. 

 

GMED’s success and high level of performance rely first and foremost on a strong and dedicated team of individuals trained at the highest level of the current evaluation and auditing methods to provide the best certification services: Certification Project Managers, Subject Matters Specialists (MDAO or Medical Device Animal Origin, Medicinal Substance, Active Implantable Medical Devices, Microbiologists), Technical Documentation Evaluators and Design Dossier Assessors, Clinical Reviewers & Experts (Ex: Sterilization Methods and Validation) and Auditors for CE marking and QMS activities. 

 

With offices in Europe and a dedicated US Operation created in 2005 - GMED North America (MD), GMED offers the convenience and efficiency of local teams of experimented specialists to accompany your certification process which will allow you to market in your target markets.

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